BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALYZER

    MDR report key: 11787 · Received March 1, 1994

    Report

    Report Number
    MW1000906
    Event Type
    Malfunction
    Date Received
    March 1, 1994
    Date of Event
    January 24, 1994
    Report Date
    January 24, 1994
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    FJI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ARRIVED IN THE DIALYSIS UNIT AMBULATORY. HE APPEARED SHORT OF BREATH; LUNGS AUSCULTATED AND BILATERAL WHEEZES WITH POOR AIR FLOW FOUND. AT 3:50 PM, DIALYSIS WAS INITIATED VIA RIGHT SUBCLAVIAN CATHETER. CATHETER WAS FUNCTIONING POORLY DUE TO THE PT'S AGITATION. AT 3:52 PM, PT BECAME EXTREMELY APPREHENSIVE, TOOK OXYGEN OFF AND SAT UP AT BEDSIDE, COLOR POOR, AND PT REFUSED TO LIE IN BED. 500 ML NORMAL SALINE AND EPINEPHRINE IV (1:10,000) GIVEN TO TRY TO RELIEVE BRONCHOSPASM. PT'S COLOR CONTINUED TO DETERIORATE AND CODE WAS CALLED AT 3:55 PM. PT APPEARED TO STOP BREATHING; HE THEN LAID FLAT IN BED AND CPR WAS INITIATED. CODE TEAM ARRIVED IMMEDIATELY. CARDIAC MONITOR SHOWED BRADYCARDIA AND ATROPINE WAS GIVEN. PT WAS INTUBATED. PT WAS AWAKE AND RESPONDED TO COMMANDS; TRANSFERRED TO CCU. (ALSO SEE 1000905 AND 1000906.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIALYZER FJI TERUMO MEDICAL CORP. C121 8893110

    Patients

    Seq Age Sex Outcome Treatment
    1 66 *